I.FLEX BY TCS

Resin, Denture, Relining, Repairing, Rebasing

THERMOPLASTIC COMFORT SYSTEMS, INC.

The following data is part of a premarket notification filed by Thermoplastic Comfort Systems, Inc. with the FDA for I.flex By Tcs.

Pre-market Notification Details

• Device ID: K123396
• 510k Number: K123396
• Device Name: I.FLEX BY TCS
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: THERMOPLASTIC COMFORT SYSTEMS, INC. 2619 LIME AVENUE Signal Hill, CA 90755
• Contact: Marlin Posca
• Correspondent: Marlin Posca; THERMOPLASTIC COMFORT SYSTEMS, INC. 2619 LIME AVENUE Signal Hill, CA 90755
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-05
• Decision Date: 2013-01-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D805500501L2222	K123396	000
D805500201S32	K123396	000
D805500201S22	K123396	000
D805500201S12	K123396	000
D805500001SCUSTOM2	K123396	000
D805500001MN2	K123396	000
D805500001MFN2	K123396	000
D805500001MFCUSTOM2	K123396	000
D805500001MF42	K123396	000
D805500001MF32	K123396	000
D805500001MF22	K123396	000
D805500201S42	K123396	000
D805500201SN2	K123396	000
D805500501L2212	K123396	000
D805500501L22	K123396	000
D805500501L12	K123396	000
D805500501FL42	K123396	000
D805500301BN2	K123396	000
D805500301BCUSTOM2	K123396	000
D805500301B42	K123396	000
D805500301B32	K123396	000
D805500301B22	K123396	000
D805500301B12	K123396	000
D805500001MF12	K123396	000
D805500001MCUSTOM2	K123396	000
D805500301B3X10	K123396	000
D805500301B35	K123396	000
D805500301B2X5	K123396	000
D805500301B2X10	K123396	000
D805500301B25	K123396	000
D805500301B1X5	K123396	000
D805500301B15	K123396	000
D805500301BCUSTOMX10	K123396	000
D805500301B3X5	K123396	000
D805500301B1X10	K123396	000
D805500301B45	K123396	000
D805500301B4X10	K123396	000
D805500001M42	K123396	000
D805500001M32	K123396	000
D805500001M22	K123396	000
D805500001M12	K123396	000
D805500301BNX5	K123396	000
D805500301BNX10	K123396	000
D805500301BN5	K123396	000
D805500301BCUSTOMX5	K123396	000
D805500301BCUSTOM5	K123396	000
D805500301B4X5	K123396	000
D805500301BCUSTOMX100	K123396	000
D805500501L2232	K123396	000
D8055005LPLCUSTOM2	K123396	000
D805500501MT25CUSTOM2	K123396	000
D805500501MT2542	K123396	000
D805500501MT2532	K123396	000
D805500501MT2522	K123396	000
D805500501MT2512	K123396	000
D805500501M22N2	K123396	000
D805500501M22CUSTOM2	K123396	000
D805500501M2242	K123396	000
D805500501M2232	K123396	000
D805500501M2222	K123396	000
D805500501MT25N2	K123396	000
D8055005JPL12	K123396	000
D8055005JPSN2	K123396	000
D8055005JPSCUSTOM2	K123396	000
D8055005JPS42	K123396	000
D8055005JPS32	K123396	000
D8055005JPS22	K123396	000
D8055005JPS12	K123396	000
D8055005JPLN2	K123396	000
D8055005JPL42	K123396	000
D8055005JPL32	K123396	000
D8055005JPL22	K123396	000
D805500501M2212	K123396	000
D805500501LT25N2	K123396	000
D805500501LFN2	K123396	000
D805500501LFCUSTOM2	K123396	000
D805500501LF32	K123396	000
D805500501LF22	K123396	000
D805500501LF12	K123396	000
D805500501LCUSTOM2	K123396	000
D805500501L42	K123396	000
D805500501L32	K123396	000
D805500501L22N2	K123396	000
D805500501L22CUSTOM2	K123396	000
D805500501LN2	K123396	000
D805500501LNZ2512	K123396	000
D805500501LT25CUSTOM2	K123396	000
D805500501LT2542	K123396	000
D805500501LT2532	K123396	000
D805500501LT2522	K123396	000
D805500501LT2512	K123396	000
D805500501LNZ25N2	K123396	000
D805500501LNZ25CUSTOM2	K123396	000
D805500501LNZ2542	K123396	000
D805500501LNZ2532	K123396	000
D805500501LNZ2522	K123396	000
D805500501L2242	K123396	000